Purpose To evaluate safety and efficacy of the Solitaire device when used as 1st choice device in the treatment of patients with acute ischemic stroke (AIS) secondary to large artery occlusion.
Methods A retrospective data collection on consecutive patients presenting with AIS treated with Solitaire device as first line device to restore blood flow in six experienced European sites from March 2009 to June 2010. An independent Core Lab evaluated TICI scores on the pre-procedure and post-procedure angiograms. Complete recanalization was defined as TICI 2b or three-post treatment. Baseline and post-treatment brain CT or MRI were also centrally reviewed to evaluate ASPECTS and symptomatic intracranial hemorrhage (SICH). The definition of SIH used is parenchymal hemorrhage type 2 + death or neurologic deterioration of 4 or more point of NIHSS. Patients were treated according to the hospitals' stroke protocols (direct IA, bridging IV t-PA/IA and failed or contraindicated IV t-PA). Sites provided patient information at pre-procedure, procedure, 24 h, discharge and 90 days. Good early neurological outcome was defined as NIHSS score improvement of ≥10 points or NIHSS 0, 1 at discharge, and favorable functional outcome as modified Rankin Scale (mRS) score ≤2 at day 90. Patients with missing mRS data were judged to have worst possible outcome for data analysis.
Results Of the 206 patients treated with Solitaire device, the device was used as first line treatment in 141 patients (mean age, 66; median NIHSS, 18): 74 patients were treated with IV t-PA prior to endovascular treatment, 56 had contra indication to IV t-PA and 11 were directly treated IA. The revascularization success independently evaluated was 85%. The mean number of recoveries was 1.8 and median time from groin puncture to successful revascularization was 40 min. Good early neurological outcome at discharge was 41% and good clinical outcome at 90 days was 55%. Sub group analysis on results according to administration or not of IV tPA pre use of Solitaire device was performed. The two sub-groups were analyzed and considered statistically similar on criteria such as age, sex, NIHSS at baseline, ASPECTS at baseline, occlusion lesion site.
Conclusions This retrospective, uncontrolled study shows the positive effect of Solitaire device in treatment of patients with acute ischemic stroke to restore flow and good clinical outcomes in patients with AIS and large artery occlusion.
Competing interests V Costalat: Covidien.